Deworming Against Tuberculosis

• Sponsor: Linkoeping University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00857116
• Collaborator: University of Gondar (Other), Armauer Hansen Research Institute, Ethiopia (Other)
• Enrollment: 140
• Location: 1
• Arms: 2
• Duration (Months): 53
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate whether treatment against intestinal helminths in patients with pulmonary tuberculosis undergoing chemotherapy could improve the clinical outcome by enhancing host immunity.

Condition or Disease	Intervention/Treatment	Phase
Tuberculosis	Drug: Albendazole; Drug: Placebo	N/A

Detailed Description

Mycobacterium tuberculosis causing tuberculosis (TB) is a major global public health problem. Because of increasing multi drug resistance and the long treatment period of at least six months, new therapeutic options are urgently needed. In countries like Ethiopia where TB is endemic, chronic worm infection is also highly prevalent. Recent data support that helminth infection might limit the host response against TB by inhibition of the TH1-response that is crucial in controlling the disease. In this study we want to test the hypothesis that Albendazole treatment of patients coinfected with helminths and TB could improve clinical outcome in addition to chemotherapy against TB. Additionally we will investigate the immunological interactions between TB and chronic helminths infection.

Study Design

• Study Type: Interventional
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: The Impact of Deworming on Host Immunity and Clinical Outcome in Patients With Pulmonary Tuberculosis
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Albendazole Albendazole 400mg per os once daily for three consecutive days	Drug: Albendazole; Albendazole 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis; Other Names: ALB
Placebo Comparator: Placebo Placebo 400mg per os for three consecutive days	Drug: Placebo; Placebo 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis

Outcome Measures

Primary Outcome Measures

1. Change in TB-score compared to baseline (Wejse et al 2007) [2 months]

Secondary Outcome Measures

1. Sputum smear conversion [3 months]

2. Final outcome according to WHO [6 months]

3. Difference in ELIspot pattern (IL5, IFN-gamma and IL-10) [3 months]

4. Immunological response (IgE, Eosinophils, CD4-count) [3 months]

5. Chest X-ray improvement [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Informed and written consent to take part in the study

• Newly diagnosed pulmonary TB patients according to the WHO definitions of active tuberculosis who have a positive stool sample for helminths other than Schistosoma spp.

Exclusion Criteria:

• Pregnancy

• Corticosteroid or antibiotic treatment

• Symptomatic (diarrhoea) infection caused by worm infection

• Chronic diseases or acute infectious diseases other than TB or HIV

• Stool sample positive for Schistosoma spp

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Gondar	Gondar, Region 3, Ethiopia	Gondar	Ethiopia

Sponsors and Collaborators

• Linkoeping University
• University of Gondar
• Armauer Hansen Research Institute, Ethiopia

Investigators

• Principal Investigator: Ebba Abate, MSc, University of Gondar and Linkoeping University
• Principal Investigator: Ermias Diro, MD, University of Gondar
• Study Director: Thomas Schoen, MD PhD, Linkoeping University, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

• Borkow G, Bentwich Z. HIV and helminth co-infection: is deworming necessary? Parasite Immunol. 2006 Nov;28(11):605-12. Review.
• Elias D, Akuffo H, Thors C, Pawlowski A, Britton S. Low dose chronic Schistosoma mansoni infection increases susceptibility to Mycobacterium bovis BCG infection in mice. Clin Exp Immunol. 2005 Mar;139(3):398-404.
• Elias D, Mengistu G, Akuffo H, Britton S. Are intestinal helminths risk factors for developing active tuberculosis? Trop Med Int Health. 2006 Apr;11(4):551-8.
• Elias D, Wolday D, Akuffo H, Petros B, Bronner U, Britton S. Effect of deworming on human T cell responses to mycobacterial antigens in helminth-exposed individuals before and after bacille Calmette-Guérin (BCG) vaccination. Clin Exp Immunol. 2001 Feb;123(2):219-25.
• Kassu A, Mengistu G, Ayele B, Diro E, Mekonnen F, Ketema D, Moges F, Mesfin T, Getachew A, Ergicho B, Elias D, Wondmikun Y, Aseffa A, Ota F. HIV and intestinal parasites in adult TB patients in a teaching hospital in Northwest Ethiopia. Trop Doct. 2007 Oct;37(4):222-4.
• Modjarrad K, Zulu I, Redden DT, Njobvu L, Lane HC, Bentwich Z, Vermund SH. Treatment of intestinal helminths does not reduce plasma concentrations of HIV-1 RNA in coinfected Zambian adults. J Infect Dis. 2005 Oct 1;192(7):1277-83. Epub 2005 Aug 25.

• Responsible Party: Thomas Schon, MD PhD, Linkoeping University
• ClinicalTrials.gov Identifier: NCT00857116
• Other Study ID Numbers: ALBP; HLF-20060245
• First Posted: Mar 6, 2009
• Last Update Posted: Aug 29, 2013
• Last Verified: Aug 1, 2013

• Keywords provided by Thomas Schon, MD PhD, Linkoeping University: Deworming; Tuberculosis; TB-score; Albendazole; Helminths
• Additional relevant MeSH terms: Tuberculosis; Albendazole

Study Results

No Results Posted as of Aug 29, 2013